Medical Device Daily

What are the number of critical patient care errors each year in U.S. hospitals?

What are the numbers of those errors that result in fatalities? The number that result in avoidable injuries?

What are the numbers of “near-miss” errors?

Rather famously, the Institute of Medicine (Washington) in 1999 reported that the number of fatalities caused by medical mistakes in the nation's hospitals could run as high as 98,000 annually, but it set the number as low as in the 40,000 range.

A pretty large range – and suggesting a good bit of grey area in determining the total figure and leaving a large window open for controversy concerning the definition of a medical error.

The controversy followed, and the rather clear fact is that the healthcare industry does not have any hard numbers on this issue.

How can it, when there are rather large, even overwhelming disincentives to report provider mistakes that result in deaths and injuries – such as liability claims against deep pocket providers and firing and other adverse personnel actions against the staff members who make the mistakes?

But U.S. healthcare may now be on the verge of having a system for providing well-documented figures concerning the number of medical mistakes and near misses, the essential baseline for determining corrective action.

This is the goal of the Patient Safety and Quality Improvement Act of 2005 that was signed into law in July of last year and is now “on the books.” But the legislation awaits the necessary unveiling of regulations which enable implementation – primarily the specifics for establishing Patient Safety Organizations (PSOs) that will collect the error and “near miss” data.

Currently, the Agency for Healthcare Research and Quality (AHRQ; Washington) “is working with various agencies,” such as the FDA, the Center for Disease Control and Prevention (Atlanta) and the Center for Medicare and Medicaid Services (Baltimore), to develop these regulations, Fara Englert, spokesperson for AHRQ, told Medical Device Daily.

She said that a “writing group” has had the goal of issuing the regulations by this summer, but she offered no guarantee that this timeline would be met. Issuance of the proposed regulations would be followed by a 60 to 90-day period for comment and then release of final regulations, with the hope that this will happen in 2006.

Determining the actual number of medical errors and near misses, thus providing confirmable numbers are the foundation issues that the patient safety act attempts to address. This then ought to provide a broad database of information in order to better understand and reduce these errors and deliver better care.

The act provides for reporting of these errors to PSOs in such a way that healthcare workers doing the reporting are protected from being fired, or other penalties, and providers doing the reporting are protected from lawsuits charging liability.

(A significant exception is if the reported information relates to a criminal action and, importantly, it cannot be obtained in any other way – a requirement involving the necessary subpoenas).

When organized and put into place, PSOs will be tasked with analyzing the data in order to understand “sentinel” events and focus on key trends. Specifically, what a PSO will create is a “patient safety work product” (PSWP) that allows the evaluation of the protected information in order to energize significant error reduction.

Overall, Englert told MDD that there has been active interest by a variety of organizations in participating in the effort and perhaps becoming a PSO, and that exact parameters for defining and regulating PSOs is a key issue to be addressed by the regulations.

As an example of one key issue, a hospital establishing a PSO may be considered to have a conflict of interest – in terms, perhaps, of under-reporting its errors and near misses – and the act already provides for the Secretary of the HHS to determine such a PSO's ability to be fair, as well as an appeal process.

Following are some of the provisions of the Patient Safety and Quality Improvement Act:

PSO guidance

  • A PSO must be certified and listed by HHS, renewing the certification every three years.
  • The PSO's mission and main activity is to conduct activities intended to improve patient safety and the quality of healthcare delivery.
  • The PSO should collect patient safety information from providers in a standardized manner that enables valid comparisons of the data (that is, similar data from similar providers).
  • The PSO reports to providers in a manner intended to minimize error and patient risk.

About PSWP confidentiality

  • The PSO must establish the security measures which maintain the confidentiality of the data and to prevent any disclosures to any related entities.
  • PSWP is privileged and cannot be disclosed to a variety of legal subpoena actions or discovery or admitted to a wide range of legal proceedings.

About PSYP disclosure

  • Disclosure can be made if it contains evidence of a criminal act and the information can be obtained in no other way, except from the PSWP.
  • Disclosure can be made if related to an adverse employment action and required.
  • Disclosure is authorized to carry out activities intended to improve patient safety.
  • Disclosure can be made to a variety of interested parties, such as researchers, under HIPAA confidentiality regulations.
  • What is the incentive for an organization to become, or establish, a PSO and collect error and near-miss data into a PSWP?
  • Incentives come in three flavors: financial, social and moral.

Given the fact that there are apparently no economic incentives built into the patient safety legislation, Englert says that those organizations that have shown interest in the effort simply want “to do the right thing.”